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CompletedNCT04800653Updated Oct 24, 2022

The Effect of Stellate Ganglion Block on Postoperative Sleep Disturbance and Cognitive Function in Elderly Surgical Patients

An interventional study of Stellate ganglion block in Stellate Ganglion Block, sponsored by Yangzhou University. Completed at 1 site in China. Open to participants aged 65 Years to 85 Years. Per ClinicalTrials.gov, last updated 2022-10-24.

Sponsored by Yangzhou University · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
48
Allocation
Randomized
Ages
65 Years to 85 Years
Sex
All
01

Study summary

Postoperative delirium is an acute state of confusion, which is characterized by changes in attention and cognitive functions and fluctuations in consciousness; postoperative cognitive dysfunction is a common central nervous system complication in elderly patients after surgery, often manifested as memory, Obstacles in abstract thinking and orientation are accompanied by a decline in social activity ability. Postoperative delirium and cognitive dysfunction can prolong hospital stay, increase medical expenses, affect postoperative functional recovery, and even increase postoperative mortality. Sleep disorders are a group of diseases that affect the ability to sleep well regularly and cause severe impairment of social and occupational functions. Stellate ganglion block is a selective sympathetic ganglion block, in which a local anesthetic is injected into the loose connective tissue of the neck including the stellate ganglion. There are complex connections between stellate ganglia and multiple brain regions in the brain, which can improve postoperative delirium, cognitive function and sleep disturbance to a certain extent, and have certain guiding significance for postoperative rehabilitation of elderly patients.

02

Conditions studied

  • Stellate Ganglion Block

Keywords

  • Delirium
  • Cognitive Dysfunction
  • Sleep Disorders
03

In context

Ganglion Cysts

136 studies on the registry are indexed under Ganglion Cysts; 28 are open to participants now.

This study's enrollment of 48 is below the median of 60 across 101 interventional studies indexed under Ganglion Cysts.

Browse Ganglion Cysts studies →

Lead sponsor

Yangzhou University is the lead sponsor of 40 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
65 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Age ≥ 60 years;
  2. ASA grade I-III;
  3. Operative time ≥ 2 h for laparoscopic radical resection of a suspected; gastrointestinal malignancy.

Exclusion criteria

Exclusion criteria :

  1. Patient's lack of consent to participate;
  2. Known allergy to anesthetic drugs;
  3. History of psychiatric or neurological disease(s);
  4. Long-term use of opioids or sedative-hypnotic drugs;
  5. Previous or planned neurosurgical procedures;
  6. contraindications to epidural anesthesia;
  7. Hearing or visual impairment that precludes scale assessment.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
48 participants (actual)

Study arms

  • Experimental
    Stellate ganglion block

    Before the operation, the left stellate ganglion block was performed, and 0.375% ropivacaine 5ml was injected into the stellate ganglion.

    Procedure: Stellate ganglion block

  • No intervention
    Control

    Do nothing

Interventions

  • ProcedureStellate ganglion block

    Find the position of the stellate ganglion under ultrasound guidance, and inject 0.375% ropivacaine near the stellate ganglion to block the sympathetic nerves in the upper chest and head and neck

06

What researchers measure

Primary outcomes

  1. Changes in the level of Mini-Men-tal State Examination scale score

    Assess the cognitive function of the patient by asking questions on the patient scale

    Time frame: The day before surgery and 1,2,3,5,7 days after surgery

  2. Changes in the level of actigraphy

    Through the actigraphy, monitor the patient's sleep quality

    Time frame: The 1st night before the operation and the 1st, 2nd and 3rd nights postoperatively

  3. Changes in the level of Pittsburgh sleep quality index

    Assess the patient's sleep quality by asking questions on the scale

    Time frame: The day before surgery and 1,2,3,5,7 days

Secondary outcomes

  1. Changes in the level of IL-1

    The outcome above should be measured at the time Preoperative, 6 am on the first day after surgery, 6 am on the third day after surgery

    Time frame: Preoperative, 6 am on the first day after surgery, 6 am on the third day after surgery

  2. Changes in the level of Systolic Blood Pressure/Diastolic Blood Pressure(Mean Arterial Pressure)

    The outcome above should be measured at the time Before induction, immediately before intubation, immediately after intubation, at the beginning of the operation, 1 hour after the beginning of the operation, and immediately after extubation at the end of the operation

    Time frame: Baseline (Before induction), immediately before intubation, immediately after intubation, at the beginning of the operation, 1 hour after the beginning of the operation, and immediately after extubation at the end of the operation

  3. Local cerebral Oxygen Saturation

    The outcome above should be measured Local cerebral oxygen saturation meter

    Time frame: Collected every 15 minutes before induction of anesthesia to 1 hour after the end of anesthesia

  4. Changes in the level of IL-10

    The outcome above should be measured at the time Preoperative, 6 am on the first day after surgery, 6 am on the third day after surgery

    Time frame: Preoperative, 6 am on the first day after surgery, 6 am on the third day after surgery

  5. Changes in the level of IL-6

    The outcome above should be measured at the time Preoperative, 6 am on the first day after surgery, 6 am on the third day after surgery

    Time frame: Preoperative, 6 am on the first day after surgery, 6 am on the third day after surgery

  6. Changes in the level of Melatonin

    The outcome above should be measured at the time Preoperative, 6 am on the first day after surgery, 6 am on the third day after surgery

    Time frame: Preoperative, 6 am on the first day after surgery, 6 am on the third day after surgery

  7. Changes in the level of Heart Rate

    The outcome above should be measured at the time Before induction, immediately before intubation, immediately after intubation, at the beginning of the operation, 1 hour after the beginning of the operation, and immediately after extubation at the end of the operation

    Time frame: Baseline (Before induction), immediately before intubation, immediately after intubation, at the beginning of the operation, 1 hour after the beginning of the operation, and immediately after extubation at the end of the operation

  8. Changes in the level of Oxygen saturation

    The outcome above should be measured at the time Before induction, immediately before intubation, immediately after intubation, at the beginning of the operation, 1 hour after the beginning of the operation, and immediately after extubation at the end of the operation

    Time frame: Baseline (Before induction), immediately before intubation, immediately after intubation, at the beginning of the operation, 1 hour after the beginning of the operation, and immediately after extubation at the end of the operation

  9. Changes in the value and waveform of Narcotrend

    The outcome above should be measured at the time Before induction, immediately before intubation, immediately after intubation, at the beginning of the operation, 1 hour after the beginning of the operation, and immediately after extubation at the end of the operation

    Time frame: Baseline (Before induction), immediately before intubation, immediately after intubation, at the beginning of the operation, 1 hour after the beginning of the operation, and immediately after extubation at the end of the operation

  10. Changes in the level of S100-β

    The outcome above should be measured at the time Preoperative, 6 am on the first day after surgery, 6 am on the third day after surgery

    Time frame: Preoperative, 6 am on the first day after surgery, 6 am on the third day after surgery

07

Study locations

1 site
  • the Affiliated Hospital of Yangzhou University
    Yangzhou, Jiangsu, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 24, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04800653
Lead sponsor
Yangzhou University
Responsible party
Zhuan Zhang (Director, Yangzhou University) — Principal investigator
First posted
Mar 16, 2021
Start date
Mar 1, 2021
Primary completion
Mar 1, 2022
Completion
Jul 12, 2022
Last update
Oct 24, 2022

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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